STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.

Recall Insight

This FDA Devices action (record #Z-1541-2013) was formally reported on June 19, 2013, with the manufacturer initiating the action on May 28, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Abbott Medical Optics, Inc. is listed as the recalling firm, operating out of Milpitas, CA. Federal records indicate 1,882, total all systems units are affected.

The documented reason for this recall is: Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Great Britian, Greece, India, Ireland, Italy, Netherlands, New Zealand, Norway, Pola…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.